MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CELLEX

Device Problem Air/Gas in Device (4062)

Patient Problems Pain (1994); Low Oxygen Saturation (2477); Cough (4457)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the oxygen that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.No product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since (b)(6) 2015.As part of the review, it was determined that the instrument's last service prior to the event was on 16-jan-2020.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.Service was dispatched for the instrument.The service technician performed the system checkout procedure and found that all of the instrument's air detectors were working correctly.In addition, the service technician performed a water treatment, including inducing air alarms.The service technician verified that the instrument activated all air alarms appropriately, including when the collect line was removed from the water source.The root cause for the patient's cough, arm pain, and oxygen desaturation could not be determined based on the available information.Trends were reviewed for complaint categories cough, pain, and oxygen desaturation.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: cough, pain, and low oxygen saturation (b)(4); s.K.: (b)(6) 2020.

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced coughing, arm pain and oxygen desaturation during a single needle mode ecp treatment procedure on (b)(6) 2020.The customer stated that at 300mls of whole blood processed, the patient experienced coughing and pain in his arm.The customer reported that she checked both the patient's peripheral iv access and the cellex photopheresis kit's ("kit") lines and noticed air in both the kit's collect and return lines.The customer stated that the air in the kit's collect and return lines was already past the instrument's air detectors.The customer reported that no alarms had occurred.The customer stated that the patient's ecp treatment procedure was then aborted.The customer reported that the patient was placed on his side, and two liters of oxygen was administered to the patient due to his oxygen saturation dropping to 91%.The customer stated that the emergency response team was called and they assessed the patient as stable.The customer reported that the patient felt fine after the administration of the two liters of oxygen and the patient was now stable.The customer stated that it was unknown if any air had reached the patient.The customer reported that the patient's physician decided that the patient was well enough to undergo a second ecp treatment procedure that day using a different instrument.The customer stated that the patient's second ecp treatment procedure was successfully completed.The customer reported that the instrument had been placed out of use pending service.The customer stated that both the kit and smartcard had been discarded.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 10871945
• MDR Text Key: 219310778
• Report Number: 2523595-2020-00124
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 81